A systematic review and meta-analysis of phase III randomized controlled trials to assess the risk of pneumonia, URTIs, and VTE in multiple myeloma patients treated with isatuximab
Abstract
Background: Multiple myeloma (MM) is a hematologic malignancy characterized by the clonal proliferation of malignant plasma cells in the bone marrow, constituting approximately 13% of all hematologic malignancies. Isatuximab is a monoclonal antibody targeting the CD38 protein on myeloma cells, causing cell death through various immune-mediated mechanisms. Clinical trials have shown that adding isatuximab to standard regimens for MM significantly enhances efficacy but introduces some notable toxicities. The purpose of this study is to determine the risk of pneumonia, upper respiratory tract infections (URTIs), and venous thromboembolism (VTE) in patients with MM treated with isatuximab.
Methods: We conducted a comprehensive literature search using Medline, Embase, and Cochrane databases from inception through July 22nd, 2024. Phase III randomized controlled trials (RCTs) utilizing isatuximab in newly diagnosed MM (NDMM) and relapsed and refractory MM (RRMM) reporting pneumonia, URTIs, and VTE as adverse events were included. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR) with 95% confidence interval (CI). Heterogeneity was assessed with Cochran's Q-statistic. Random effects model was applied.
Results: A total of 1,044 patients from three phase III RCTs (ICARIA-MM, IKEMA, IMROZ) were included for pneumonia and URTI analysis, while 1,403 patients from three trials (IKEMA, IMROZ, GMMG-HD7) were included for VTE evaluation. The incidence of…
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Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 1,403 participants or records.
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